Optimizing evidence-based HIV prevention targeting people who inject drugs on PrEP

针对 PrEP 注射吸毒者优化基于证据的艾滋病毒预防

• 批准号: 10548320
• 负责人: MICHAEL COPENHAVER
• 金额: $ 60.56万
• 依托单位: UNIVERSITY OF CONNECTICUT STORRS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10548320
• 关键词: AIDS prevention; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Adherence; Alzheimer' s Disease; American; Analgesics; Area; Attention; Attention deficit hyperactivity disorder; Behavior; Behavioral; Budgets; Centers for Disease Control and Prevention (U.S.); Characteristics; Cognitive; Cognitive deficits; Communities; Disease Outbreaks; Enrollment; Evidence based intervention; Exhibits; Funding; Funding Opportunities; Goals; Guidelines; HIV; HIV Infections; HIV risk; Health; Health Promotion; Health behavior; Health behavior change; Impaired cognition; Incidence; Individual; Injectable; Injecting drug user; Intervention; Knowledge; Measurement; Measures; Mediator of activation protein; Memory; Methods; Modeling; Motivation; Neurologic; Opioid; Outcome; Participant; Patient Self-Report; Patients; Performance; Persons; Pharmaceutical Preparations; Pharmacotherapy; Prevention approach; Process; Public Health; Recovery; Research; Research Priority; Risk Behaviors; Risk Reduction; Risk Reduction Behavior; Science; Study models; Traumatic Brain Injury; United States National Institutes of Health; Update; Work; base; cognitive function; cognitive testing; comorbidity; cost; cost effectiveness; design; evidence base; executive function; experience; follow-up; frontier; future implementation; high risk population; information processing; innovation; medication compliance; memory process; multiphase optimization strategy; opioid epidemic; opioid use disorder; overdose death; patient population; post intervention; pre-exposure prophylaxis; prevent; primary outcome; programs; response; secondary outcome; sex; skills; transmission process; treatment program; treatment services; trend

Framed by the multiphase optimization strategy (MOST), and building on our recent preliminary studies, we are requesting 5 years of support to conduct an optimization trial among people who inject drugs (PWID) and newly enrolled on medication for opioid use disorder (MOUD). The goal is to assess the performance of four intervention components (Attention, Executive Functioning, Memory, and Information Processing) aimed at enhancing the ability of PWID on MOUD to process and utilize evidence-based HIV prevention content, leading to improvements in Pre-Exposure Prophylaxis (PrEP) adherence and HIV risk reduction. Existing evidence-based interventions require participants to have at least moderate levels of cognitive functioning but do not acknowledge or accommodate participants with cognitive dysfunction. This is a crucial weakness as cognitive dysfunction is a common feature among PWID, and one that can directly impede their ability to process and utilize intervention content. In fact, our recent studies comparing objective and self-report cognitive assessments (e.g., NIH toolbox) show that ~67% of PWID experience substantial levels of cognitive dysfunction across tasks involving attention, executive function, memory, and information processing that, in turn, disrupt the expected intervention outcomes (e.g., medication adherence, HIV risk reduction). Our recent work also suggests that PWID newly enrolled on MOUD would benefit from an intervention approach that incorporates ‘compensatory strategies’ to accommodate their cognitive dysfunction. A number of well-established compensatory strategies have been successfully applied to other patient populations (e.g., traumatic brain injury, ADHD, Alzheimer’s/dementia) and have been identified by our team as promising intervention components that could enhance evidence-based PrEP-focused primary HIV prevention approaches targeting PWID on MOUD. To date, however, no studies have examined the potential impact and cost of incorporating such intervention components, either individually or in various combinations, in terms of enhancing PWID’s ability to process and utilize HIV prevention content. This innovative trial will be the first to use the MOST framework to optimize an evidence-based HIV prevention approach by compensating for cognitive features that are characteristic of PWID on MOUD, and maximizing PrEP adherence outcomes within real world budget constraints.

框架的多相优化策略（MOST），并建立在我们最近的 初步研究，我们要求5年的支持，以进行优化试验， 注射毒品（PWID）和新登记的阿片类药物使用障碍患者 （MOUD）。目标是评估四个干预组成部分（注意， 执行功能，记忆和信息处理），旨在提高 在MOUD上处理和利用循证艾滋病毒预防内容， 改善暴露前预防（PrEP）依从性和降低艾滋病毒风险。现有 基于证据的干预措施要求参与者至少具有中等水平的认知能力， 功能正常，但不承认或容纳认知功能障碍的参与者。 这是一个关键的弱点，因为认知功能障碍是PWID的共同特征， 这会直接妨碍他们处理和利用干预内容的能力。其实我们 最近比较客观和自我报告认知评估的研究（例如，NIH工具箱） 显示约67%的PWID在不同任务中经历了相当程度的认知功能障碍， 包括注意力、执行功能、记忆和信息处理，反过来， 破坏预期的干预结果（例如，药物依从性，降低艾滋病毒风险）。 我们最近的研究还表明，新加入MOUD的PWID将受益于 干预方法，包括“补偿战略”，以适应他们的 认知功能障碍一些行之有效的补偿策略已经被 成功地应用于其他患者群体（例如，创伤性脑损伤多动症 阿尔茨海默氏症/痴呆症），并已被我们的团队确定为有希望的干预措施 可以加强以PrEP为重点的循证初级艾滋病毒预防的组成部分 在MOUD上针对PWID的方法。然而，到目前为止，还没有研究检查过 单独或单独纳入这些干预组成部分的潜在影响和费用 在各种组合中，在增强PWID处理和利用HIV的能力方面， 预防内容。这一创新试验将首次使用MOST框架来优化 一种基于证据的艾滋病毒预防方法， PWID在MOUD上的特征，并在真实的世界中最大化PrEP依从性结果 预算限制。